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Botox King Challenged by Rivals and Skeptics

Posted on: Thursday, 29 May 2008, 09:10 CDT

SANTA ANA, Calif. -- Botox is king, the undisputed sovereign of cosmetic medicine.

For now.

No other cosmetic treatment comes close to matching its popularity, but usurpers and naysayers surround the throne.

Last year, Botox manufacturer Allergan sold $1.2 billion worth of the botulinum toxin, which is injected to paralyze the facial muscles that cause wrinkles.

Despite the successes of King Botox, would-be challengers lurk, while hecklers point accusatory fingers at the monarch.

The potential challengers are backed by companies such as Mentor of Santa Barbara, Calif., and Medicis Pharmaceutical of Scottsdale, Ariz., which are working on rival formulations.

Critics include Botox skeptics who point to research showing that the botulinum toxin doesn't all stay where it's injected _ some of it migrates to nearby muscles, and some even gets into the brain.

All that exasperates Botox enthusiasts.

"Since its approval, over a million people have been treated with Botox Cosmetic. In its entire history, there has never been a single reported death where a causal link to Botox Cosmetic was established," said Dr. Sef Kurstjens, Allergan's chief medical officer.

So far, the only apparent impact on Botox has been from the economy. As of the first quarter, Botox revenue in the United States were up an estimated 10 percent from a year earlier _ down from a 20 percent pace as of early 2007. "Weak consumer spending behavior" is to blame, said David Pyott, chief executive of Irvine, Calif.-based Allergan.

Here's a quick look at nine of the challenges facing Botox:

RIVALS

Reloxin: A rival formulation called Reloxin is awaiting approval from the Food and Drug Administration. Reloxin would be marketed by Medicis, which hopes for FDA action by early 2009 so Reloxin could go on sale in the U.S. next year.

World of toxins: Beyond Reloxin, a number of companies worldwide sell botulinum toxin injections for a variety of conditions, including tight neck muscles and wrinkles. Among eight existing or potential competitors, Purtox and Xeomin appear closest to reaching the domestic cosmetic market, after Reloxin.

Purtox: Mentor is conducting clinical trials for what it calls a "next-generation" wrinkle fighter that, like Botox, is made from weakened botulinum toxin.

Xeomin: The German drug company Merz Pharmaceuticals already sells the botulinum toxin Xeomin in Europe and has started U.S. clinical trials for cosmetic uses and more.

"No-needle Botox": For even further in the future, Medicis has its eye on a potential no-needle rival for Botox, in gel form. That technology, called RT-001-CS, is still in its development stage, but Medicis thought it promising enough to pay $20 million for an option to buy it. For that price, Medicis purchased 10 percent of drug developer Revance Therapeutics of Mountain View, Calif., plus an option to buy the company or to acquire an exclusive North American license for the gel.

FOR ALLERGAN: Rivals might cut into Botox revenue, either by stealing market share or through competitive pricing. Worst case for Allergan _ the Revance gel might prove to be as safe and effective as Botox.

FOR PATIENTS: If you're a person who wants to banish wrinkles, FDA approval of any of the Botox rivals would provide you and your physician with an additional method for accomplishing that. Best case for patients _ the Revance gel might prove to be as safe and effective as Botox.

HEALTH WORRIES

Researchers and consumer advocates recently publicized a spate of worrisome examples about what Botox might do if it's used to excess in cats, mice, rats and humans.

16 deaths, 1 death, no death: The FDA said in February that it was looking into cases of patients who died after they were injected with Botox or a similar non-cosmetic drug, Myobloc. The agency agreed to consider a request for stronger warning labels on the drugs.

Although 16 patients died after the injections, 15 of the 16 were being treated with powerful therapeutic-strength injections of botulinum toxin for disorders such as juvenile cerebral palsy. Only one of the 16 patients had injections of cosmetic-strength Botox.

Even in that case, the connection was tenuous. The Botox injections were seven weeks before the 47-year-old woman died from complications associated with staphylococcus pneumonia.

Possible relapses: In March, former Allergan adviser Arnold Klein, a UCLA dermatologist, suggested that Botox patients might end up with deeper wrinkles after discontinuing injections than the wrinkles they had beforehand. That's not the common experience of Botox users, yet it's the implication of data in an unpublished chart that was prepared in a 2003 study, Klein said. He doesn't dispute the safety of Botox when used properly but said it can be hazardous if misused, including injections of diluted concentrations of the drug.

Botox in cats' muscles: Researchers at the University of Calgary in Canada reported in March that strong doses of Botox injected in a cat's face can weaken nearby muscles.

What does that mean for human patients? Not much, since the dosage in the Calgary study was far above what's used for fighting wrinkles. But to be safe, patients should make sure the person injecting them with Botox is a trained medical professional.

Toxin in rodents' brains: Italian researchers reported in April that when strong doses of botulinum toxin were injected into the whisker muscles of rats and mice, some of it was absorbed into nearby nerve cells, which transmitted it via other nerve cells to the brain stem.

Those findings are at odds with the results of previous experiments, including ones conducted before Botox was approved for eye spasms in 1989 and for cosmetic uses in 2002. Allergan and researchers agreed: More studies are needed.

FOR ALLERGAN: News coverage about potential hazards conceivably could have contributed to the slowdown in Botox sales, but no consumer studies have found that it did. Local cosmetic doctors say their patients are worried about the economy, not about whether Botox is unsafe.

FOR PATIENTS: When you read about the latest Botox studies, you're likely to keep whatever preconceptions you started with, since none of the research comes close to reaching a clear, undisputed outcome.

If you think it's crazy to let someone inject a toxin into your body, headlines such as "Botox goes to the brain" can reinforce a belief that Botox users must be crazy. "Down with Botox!" will still be your motto.

If you hate wrinkles and think a million Botox users can't be wrong, you won't worry about what may have happened in a rat's brain or a cat's face. You'll still say, "Long live King Botox."

Source: The Orange County Register

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